Monitoring the IMmUological TOXicity of Drugs

NCT03480529 | Completed FDA Drug

• 1 other identifier: CIC1421-18-05
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 2

Brief Summary

Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Conditions

Arthritis; Systemic Lupus Erythematosus; Rheumatoid Arthritis; Capillary Leak Syndrome; Hepatitis

Keywords

adverse event; arthritis; Systemic Lupus Erythematosus; Capillary Leak Syndrome; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Secondary Outcomes (7)

• Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

• Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

• Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

• Description of the duration of treatment when the toxicity happens (role of cumulative dose)

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

• Description of the drug-drug interactions associated with adverse events

  Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Study Arms (1)

Arthritis or lupus or CLS induced by a drug

Case reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak syndrome of patient treated by a drug, with a chronology compatible with the drug toxicity

Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

Interventions

drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom DRUG

Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Arthritis or lupus or CLS induced by a drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

You may qualify if:

• Case reported in the WHO's pharmacovigilance database till 02/01/2018
• Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome.

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, 75013, France

Location

Rhumatology department, CHU Strasbourg, Hautepierre hospital

Strasbourg, 67098, France

Location

Related Publications (3)

• Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3. No abstract available.

  PMID: 29724725 RESULT

• Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20. No abstract available.

  PMID: 30244023 RESULT

• Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4.

  PMID: 30793701 RESULT

MeSH Terms

Conditions

Arthritis; Lupus Erythematosus, Systemic; Arthritis, Rheumatoid; Capillary Leak Syndrome; Hepatitis

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Rheumatic Diseases; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: March 1, 2018
• Primary Completion: March 10, 2018
• Study Completion: March 10, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)